Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01701661
First received: October 3, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.


Condition Intervention
Venous Insufficiency
Procedure: Operative treatment
Other: conservative treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Symptom relief [ Time Frame: two years ] [ Designated as safety issue: No ]
    Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
    Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).


Enrollment: 153
Study Start Date: September 2004
Study Completion Date: September 2012
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conservative treatment
Compression stockings class II
Other: conservative treatment
Compression stockings class II
Active Comparator: Operative treatment
stripping of main trunk or if previously removed, removal or ligating the refloating trunk
Procedure: Operative treatment
stripping of main trunk or if previously removed, removal or ligating the refluating trunk

Detailed Description:

Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with chronic superficial vein insufficiency
  • patient must be 20-70 years old
  • degree of difficulty of vein insufficiency C2-C3
  • venous disability score 1-2
  • patient is agreeable to the study

Exclusion Criteria:

  • peripheral atherosclerotic occlusive disease
  • lymphoedema
  • severe concomitant disease (ASA 3-5)
  • venous ulcers or unclassified skin changes
  • BMI more than 35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701661

Locations
Finland
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Maarit Venermo, MD,PhD Department of Vascular Surgery, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Maarit Venermo, MD,PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01701661     History of Changes
Other Study ID Numbers: TYH4209
Study First Received: October 3, 2012
Last Updated: October 4, 2012
Health Authority: Finland: Institutional Review Board

Keywords provided by Helsinki University Central Hospital:
venous surgery
compression therapy

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014